Rosuvastatin Denk 10mg tablets film-coated

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

rosuvastatin (rosuvastatin calcium)

Disponível em:

Pharmaceutical Works Polpharma S.A.

Código ATC:

C10AA07

DCI (Denominação Comum Internacional):

rosuvastatin (rosuvastatin calcium)

Dosagem:

10mg

Forma farmacêutica:

tablets film-coated

Unidades em pacote:

(30/3x10/) in blister

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2019-01-18

Folheto informativo - Bula

SPECIFICATION - DENK PHARMA
product name:
Rosuvastatin Denk 10 mg
artwork:
leaflet
language(s):
EN, FR, PT
material number:
50001347/005
storage
conditions:
25°C
revision of text:
07/2022
open format:
700 x 180 mm
fold:
2 x pre-folded (Wickelfalz)
folded format:
235 x 180 mm
pharma code:
-
paper grammar:
40 g/m
2
printing colours:
 PANTONE YELLOW C
 BLACK
revision/date:
1 / 19.07.2022, RSt
_Rosuvastatin Denk 10 mg_
Film-coated tablet – oral use
Lipid-lowering agent
Active substance: rosuvastatin
Package leaflet: Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPOR-
TANT INFORMATION FOR YOU.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doc-
tor or pharmacist.
– This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
–
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. WHAT ROSUVASTATIN DENK 10
MG IS AND WHAT IT IS
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ROSUVASTATIN DENK 10
MG
3. HOW TO TAKE ROSUVASTATIN DENK 10
MG
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ROSUVASTATIN DENK 10
MG
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Rosuvastatin Denk 10
mg is and
what it is used for
Rosuvastatin Denk 10 mg belongs to a group of medi-
cines called statins.
You have been prescribed Rosuvastatin Denk 10 mg
because:
• You have a high cholesterol level. This means you are
at risk from a heart attack or stroke. Rosuvastatin
Denk 10 mg is used in adults, adolescents and chil-
dren 6 years or older to treat high cholesterol.
You have been advised to take a statin, because chan-
ging your diet and getting more exercise were not
enough to correct your cholesterol levels. You should
continue with your cholesterol-lowering diet and exer-
cise while you are takin

Características técnicas

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Denk 5 mg
Rosuvastatin Denk 10 mg
Rosuvastatin Denk 20 mg
Rosuvastatin Denk 40 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: rosuvastatin
_Rosuvastatin Denk 5 mg _
Each film-coated tablet of Rosuvastatin Denk 5 mg contains 5 mg
rosuvastatin (as rosuvastatin
calcium).
Excipient with known effect: Each film-coated tablet contains 41.572
mg of lactose monohydrate and
less than 1 mmol sodium (23 mg).
_Rosuvastatin Denk 10 mg _
Each film-coated tablet of Rosuvastatin Denk 10 mg contains 10 mg
rosuvastatin (as rosuvastatin
calcium).
Excipient with known effect: Each film-coated tablet contains 83.145
mg of lactose monohydrate and
less than 1 mmol sodium (23 mg).
_Rosuvastatin Denk 20 mg _
Each film-coated tablet of Rosuvastatin Denk 20 mg contains 20 mg
rosuvastatin (as rosuvastatin
calcium).
Excipient with known effect: Each film-coated tablet contains 166.29
mg of lactose monohydrate and
less than 1 mmol sodium (23 mg).
_Rosuvastatin Denk 40 mg _
Each film-coated tablet of Rosuvastatin Denk 40 mg contains 40 mg
rosuvastatin (as rosuvastatin
calcium).
Excipient with known effect: Each film-coated tablet contains 332.58
mg of lactose monohydrate and
less than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Rosuvastatin Denk 5 mg _
White or almost white, round and biconvex film-coated tablets,
engraving “5” on one side.
_Rosuvastatin Denk 10 mg _
White or almost white, round and biconvex film-coated tablets,
engraving “10” on one side.
_Rosuvastatin Denk 20 mg _
White or almost white, round and biconvex film-coated tablets,
engraving “20” on one side.
2
_Rosuvastatin Denk 40 mg _
White or almost white, oblong and biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypercholesterolaemia
Adults, adolescents and children aged 6 years or older with primary
hypercholesterolaemia (type IIa
including hete